Evaluation of PENG Block in Terms of Block Time and Postoperative Pain

November 4, 2024 updated by: Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital

Evaluation of PENG Block Applied in Hip Surgery in Terms of Block Duration and Postoperative Pain

Hip fracture is a common orthopedic emergency in the elderly and causes significant morbidity and is associated with mortality. In most patients, surgical reduction and fixation is the definitive treatment. Effective perioperative analgesia minimizing the need for opioids and related side effects is recommended in this patient population. Therefore, various methods are used. When the investigators look at the literature, for PENG block It is observed that different drug doses (20cc, 30cc, and 40cc) are used. In this study, the investigators planned to investigate the effectiveness of PENG blocks, postoperative analgesia, and side effects.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients in the ASA 1-3 group who had hip surgery with PENG block for any reason will be included in the study. Approximately 60 patients will participate in the study, the number will be finalized as a result of power analysis. The routine algorithm for patients who will undergo hip surgery is spinal or general anesthesia after peripheral block for postoperative analgesia. Before the block, all patients were monitored by standard monitoring and intravenous vascular access was opened. For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and local anesthetic is administered by intermittent aspiration. Although drug doses vary according to the patient and the surgery to be performed in our clinic, %0.25 bupivacaine is used in 20cc, 30cc and 40cc doses. In all patients with block, 30 minutes after the block application, motor and sensory examination is carried out. Sensory block was evaluated by cold stimulus (0 = no cold sensation, 1 = cold sensation severely reduced, 2 = cold sensation slightly decreased, 3 = normal cold sensation). In patients who will undergo hip surgery, due to limited kidney and liver reserves opioids are often used for analgesia. In our clinic, to reduce opioid use in this elderly patient group, preoperative nerve block method is used. Postoperative analgesic needs of the patients will be recorded from the information in the current patient controlled analgesia device. Demographic data of patients, surgical method and duration from the anesthesia form will be followed. Postoperative numerical evaluation scale (NRS-numeric rating scale; 0 = no pain, 10 = excruciating pain) will be recorded. Postoperative pain, muscle strength, block time and nausea-vomiting PACU, 4, 8, 24 hours will be recorded. Postoperative pain treatment satisfaction of patients numerically scale (NRS, 0 = dissatisfied, 10 = extremely satisfied) and postoperative first night sleep quality at 24 hours with NRS (0= could not sleep all night, 10= slept very well) query will be recorded.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • university of health siences diskapi yildirim beyazit T&R hospital
      • Ankara, Turkey, 06450
        • Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Patients who have undergone hip surgery with PENG block for any reason

Exclusion Criteria:

  • chronic opioid users
  • cognitive disorders
  • written consent form haven't get
  • history of relevant drug allergy
  • infection of the skin at the site of needle puncture area
  • coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PENG Block with 0.25% bupivacaine (20 cc)
For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 20cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.
Peng block was performed.
Experimental: PENG Block with 0.25% bupivacaine (30 cc)
For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 30cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.
Peng block was performed.
Experimental: PENG Block with 0.25% bupivacaine (40 cc)
For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 40cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.
Peng block was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of postoperative pain
Time Frame: 0 hour
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
0 hour
The degree of postoperative pain
Time Frame: 4 hour
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
4 hour
The degree of postoperative pain
Time Frame: 8 hour
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
8 hour
The degree of postoperative pain
Time Frame: 24 hour
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
24 hour
Postoperative tramadol consumption
Time Frame: 24 hour
total tramadol consumption in three groups will be assessed in the postoperative period
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative tramadol consumption
Time Frame: 0 hour
total tramadol consumption in three groups will be assessed in the postoperative period
0 hour
Postoperative tramadol consumption
Time Frame: 4hour
total tramadol consumption in three groups will be assessed in the postoperative period
4hour
Postoperative tramadol consumption
Time Frame: 8 hour
total tramadol consumption in three groups will be assessed in the postoperative period
8 hour
Postoperative tramadol consumption
Time Frame: 24 hour
total tramadol consumption in three groups will be assessed in the postoperative period
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Actual)

July 2, 2024

Study Completion (Actual)

August 10, 2024

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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